A Prospective, Randomized, Open Label Study of Piperacillin/Tazobactam Versus Imipenem/Cilastin for Empirical Therapy of Febrile Patients With Neutropenia After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Clinical success rate.
研究概览
简要总结
Neutropenia is very common in patients received hematopoietic stem cell transplantation, with median duration of about 14 days. In 2010 update, IDSA recommended Piperacillin/tazobactam as first-line mono-therapy for febrile patients with neutropenia of high risk. In china, the data of piperacillin/tazobactam for febrile neutropenia after hematopoietic stem cell transplantation is very limited.
The current study will evaluate the efficacy of piperacillin/tazobactam compared with imipenem/cilastatin for febrile neutropenia after transplantation.
详细描述
- Swab culture (skin, pharyngeal, nasal, anus) when administered into laminar flow room after transplantation.
- Randomize the febrile patients into 2 groups.
- Therapy group receive piperacillin/tazobactam, 4.5g q6h iv. Control group receive imipenem/cilastatin, 0.5g q6h. Duration will be 5-10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-65 years
- •received Autologous or Allogeneic hematopoietic stem cell transplantation.
- •ECOG score 0-
- •ICF is available.
排除标准
- •Allergic to any therapy drug.
- •Documented infection before neutropenia.
- •Renal dysfunction.
- •Suffering from central nervous system or mental disease.
研究组 & 干预措施
piperacillin/tazobactam
干预措施: Piperacillin-tazobactam combination product (Drug)
imipenem/cilastatin
干预措施: Imipenem (Drug)
结局指标
主要结局
Clinical success rate.
时间窗: 3 weeks after beginning of empirical therapy
Resolve of clinical symptoms and signs, without change of therapy.
次要结局
- Microbiologic success rate(3 weeks after beginning of empirical therapy)
- Adverse effect(3 weeks after beginning of empirical therapy)
- Cost of drug and therapy(3 weeks after beginning of empirical therapy)
研究者
Wenrong Huang
Associate director, Hematology, Chinese PLA General hospital
Chinese PLA General Hospital